Human urinary kallidinogenase (HUK) is a tissue kallikrein extracted from human urine. Under certain conditions, tissue kallikrein can convert kininogen into kallidin and kinins, thereby promoting vascular endothelial function, and exerting anti-inflammatory and antioxidant effects. Preclinical and clinical studies have demonstrated that HUK can salvage the ischemic penumbra and significantly promote the establishment of collateral circulation. Existing research suggests that the combination of HUK with intravenous alteplase significantly improves neurological function in patients with acute ischemic stroke (AIS) without increasing the risk of hemorrhage. However, whether its combination with tenecteplase can further enhance neurological recovery in patients remains unreported. Based on the above discussion, this study aims to investigate the efficacy and safety of combining tenecteplase with HUK in the treatment of AIS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Human Urinary Kallidinogenase is administered intravenously, with 0.15 PNA units dissolved in 100 ml of normal saline.
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, China
RECRUITINGproportion of excellent functional outcome (modified Rankin Scale (mRS) 0-1)
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Time frame: 90±7 days
proportion of modified Rankin Scale (mRS) 0-2
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Time frame: 90±7 days
ordinal distribution of modified Rankin Scale (mRS)
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Time frame: 90±7 days
change in National Institute of Health stroke scale (NIHSS) score
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome
Time frame: 24 (-6/+12) hours
change in National Institute of Health stroke scale (NIHSS) score
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome
Time frame: 10±2 days
occurrence of early neurological improvement (ENI)
ENI is defined as more than 4-point decrease in National Institute of Health stroke scale score
Time frame: 24 (-6/+12) hours
new stroke or other vascular event(s)
Time frame: 90±7 days
symptomatic intracranial hemorrhage (sICH)
sICH was defined as any evidence of bleeding on the head computed tomographic scan associated with clinically significant neurological deterioration (≥4-point increase in NIHSS score).
Time frame: 24 (-6/+12) hours
major systemic bleeding events
Bleeding leading to a decrease in hemoglobin ≥ 2 g/dL or transfusion of ≥ 2 units of blood.
Time frame: 24 (-6/+12) hours
any bleeding events
Including skin and mucosal bleeding, gingival bleeding, bleeding at other organ sites, and other types of hemorrhage.
Time frame: 24 (-6/+12) hours
any intracranial hemorrhage
Heidelberg Bleeding Classification
Time frame: 10±2 days
all-cause mortality
death from any cause
Time frame: 90±7 days
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